Heart Disease Trial, Recruiting

Written by an AI model from the ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• People aged 18 to 90 years old at the time of screening
• People whose heart's pumping strength (left ventricular ejection fraction) is below 50%, measured within the 90 days before the procedure
• People who are considered high-risk due to one or more of the following heart artery conditions: a blockage in the main left coronary artery; having only one remaining working heart artery; significant blockages in three heart arteries; significant blockages in two heart arteries with complex features; a complex blockage in one artery combined with a fully blocked artery that was not treated; a fully blocked artery where the planned procedure involves approaching it from behind; or calcium buildup requiring special removal treatment (such as rotational tools, sound waves, or laser) — in more than one artery, in the main left artery, in a final working bypass graft, or where the overall complexity score is 32 or higher (confirm with trial site)
• People whose case has been reviewed by both an interventional cardiologist and a cardiac surgeon, who have agreed that a heart procedure (PCI) supported by a mechanical heart-assist device is appropriate
• People whose groin artery (the planned entry point for the device) measures greater than 5.5 mm, confirmed by CT scan or ultrasound
• People who are willing and able to attend all required follow-up visits and follow the study procedures
• People who have been fully informed about the trial and have signed a written consent form approved by an ethics committee

Who may not be able to join:

• People who have had a heart artery procedure or attempted procedure within the 30 days before the planned procedure
• People who have had a major type of heart attack (STEMI) within the 7 days before the planned procedure
• People who have had a certain type of heart attack (non-STEMI) within 7 days before the procedure, where specific heart damage markers in the blood are still elevated and not coming down
• People who have had a cardiac arrest requiring resuscitation or electric shock treatment within the 7 days before the planned procedure
• People who have a history of sustained or repeated episodes of a serious fast heart rhythm problem (ventricular tachycardia), or frequent abnormal heartbeats of a certain type
• People who currently have a blood clot in the left chamber of the heart
• People with significant right-side heart failure, as shown on an ultrasound of the heart
• People with known severe high blood pressure in the lungs (pulmonary hypertension), based on specific pressure measurements
• People experiencing combined heart and lung failure at the same time
• People who have a hole between the upper or lower chambers of the heart (including one caused by a heart attack)
• People with certain structural heart muscle conditions, including hypertrophic obstructive cardiomyopathy, restrictive cardiomyopathy, or constrictive pericarditis
• People in cardiogenic shock, where the heart is pumping too little blood to meet the body's needs (based on a specific measurement)
• People who have required medications to stimulate the heart or raise blood pressure within 72 hours before the planned procedure (note: brief use during anaesthesia for the procedure itself may be acceptable — confirm with trial site)
• People who have used a mechanical heart-assist device or a lung-and-heart bypass machine within the 14 days before the planned procedure
• People with severe disease or a replacement of the aortic heart valve
• People with blood vessel disease that would prevent a mechanical heart-assist device from being safely placed
• People who have had a stroke within the 180 days before the planned procedure
• People who have had a mini-stroke (transient ischaemic attack) within the 90 days before the planned procedure
• People with known or suspected blood clotting problems, including low platelet counts, abnormal clotting test results, or low fibrinogen levels
• People with known diseases affecting the red blood cells, such as sickle cell anaemia, haemolytic anaemia, or thalassaemia
• People who have an active infection on the day of the planned procedure that requires antibiotics (taken by mouth or through a drip)
• People with an active infection at the site where the device would be inserted
• People with severely reduced kidney function (eGFR below 30) or those who are on dialysis
• People with known liver disease involving significantly elevated liver enzymes and bilirubin (more than three times the normal upper limit) within the 90 days before the planned procedure
• People with known severe lung disease, such as very low lung airflow capacity (FEV1 below 1.0 L/s)
• People with known allergies or serious sensitivities to anaesthesia, heparin, aspirin, certain blood-thinning medications, or contrast dye used in imaging — including a history of a condition called heparin-induced thrombocytopenia (HIT)
• People with a non-heart-related medical condition where life expectancy is less than one year
• People who are currently on a breathing machine (ventilator) or were recently on one and have not been off it for more than 24 hours with full neurological recovery (a breathing tube used only for the procedure itself may be acceptable — confirm with trial site)
• People with worsening heart failure requiring intravenous diuretics, blood pressure-raising medications, or heart-stimulating medications within 72 hours of the planned procedure
• People who have had an organ transplant
• People who already have a surgically implanted left ventricular assist device
• People with fluid pressing on the heart from the outside (cardiac tamponade)
• People with a tear or rupture in the left chamber of the heart
• People who are pregnant, breastfeeding, or planning to become pregnant during the study
• People whose anatomy would physically prevent a mechanical heart-assist device from being guided through the groin artery into the heart
• People who, in the opinion of the study investigator, have medical, social, or psychological circumstances that would prevent them from giving proper consent or following study procedures
• People who are currently taking part in another clinical trial of an investigational drug or device
• People for whom it is expected that the mechanical heart-assist device will need to remain in place after the heart procedure is completed

Important: Always verify eligibility with the trial site directly before applying.